Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PROMIS Pain Interference
研究概览
简要总结
Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online pain educations programs among adult patients with inflammatory bowel disease (IBD) who experience chronic pain. Each online program can be accessed on the patient's personal device, and will take about 2 hours to complete. Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8-weeks post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-confirmed diagnosis of Crohn's disease or ulcerative colitis
- •Chronic pain (visceral and/or somatic) related to IBD for at least 3 months
- •NIH PROMIS Pain Interference scale T-score ≥60
- •Medically stable, defined as:
- •No acute IBD-related hospitalization within the past 3 months; AND
- •No planned IBD surgery or planned therapeutic escalation within the next 2 months, including initiation of a new advanced therapy, dose escalation or switch of advanced therapy, or corticosteroid taper
- •Able to understand and complete questionnaires independently in English
- •Access to an internet-enabled device for online surveys and intervention access.
排除标准
- •Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation
- •Current use of standing opioid medications, given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia
- •Prior participation in cognitive behavioral therapy (CBT) specifically targeting chronic IBD-related pain
结局指标
主要结局
PROMIS Pain Interference
时间窗: Baseline, then weekly post-treatment (Weeks 1-8)
Pain interference as measured by the validated 8-item PROMIS Pain Interference (PROMIS-PI) scale. It assesses self-reported consequences of pain on relevant aspects of one's life, including the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life. This instrument is universal, rather than disease-specific. The recall period for this scale is 7 days.
次要结局
- PROMIS Pain Intensity(Baseline, then weekly post-treatment (Weeks 1-8))
- PROMIS Abdominal Pain(Baseline, then weekly post-treatment (Weeks 1-8))
- Pain Catastrophizing Scale(Baseline, then at Weeks 4 and 8 post-treatment)
- Pain Self-Efficacy(Baseline, then at Weeks 4 and 8 post-treatment)
- Inflammatory Bowel Disease Disability Index(Baseline, then at Weeks 4 and 8 post-treatment)
- IBD Control Questionnaire(Baseline, then at Weeks 4 and 8 post-treatment)
研究者
Christopher Almario
Associate Professor of Medicine
Cedars-Sinai Medical Center